Pharmacovigilance

Roles & Responsibilities
• Design, develop, and maintain procedures for medical review activities including ICSRs, aggregate reports, and signal management
• Perform medical review of ICSRs, PSURs/PBRERs, Risk Management Plans (RMPs), and signal reports
• Ensure high quality and regulatory compliance of aggregate and signal management deliverables
• Participate in and organize safety label update reviews
• Support signal detection and evaluation activities
• Mentor and train medical reviewers within the PV team
• Provide product and therapeutic area training for pharmacovigilance teams
• Conduct cross-functional PV training for medical writing and ICSR team members

Qualification
• MBBS (MCI Registered or FMGE Qualified)

Experience
• 0–3 years of Pharmacovigilance experience
• Expertise in medical review of aggregate reports (PSURs/PBRERs) – Required
• Experience in medical review of signal management and ICSRs – Recommended

Skills
• Strong knowledge of global PV regulations and medical review standards
• Expertise in aggregate report evaluation and benefit-risk assessment
• Understanding of signal management processes
• Strong analytical and clinical evaluation skills
• Training and mentoring capabilities
• Excellent communication and documentation skills

About the Company
The Accenture is with a reputed pharmaceutical company engaged in global pharmacovigilance operations. The organization focuses on high-quality safety review, regulatory compliance, and continuous professional development within its pharmacovigilance and medical review teams.